SDTM Programmer

NO THIRD PARTIESPosition SummaryA clinical-stage biotech company based in the Bay Area is seeking a Senior Statistical Programmer to provide long-term contract support. The organization is focused on the development of oncology therapeutics, and with a growing pipeline, the programming team requires additional senior-level expertise.This role will specifically focus on CDISC SDTM standards, requiring deep, hands-on experience in SDTM mapping and implementation for oncology clinical trials. The ideal candidate will be a subject matter expert in SDTM who can lead dataset development efforts, ensure regulatory compliance, and provide technical guidance to cross-functional teams.Key ResponsibilitiesLead the development, mapping, and implementation of CDISC SDTM datasets for oncology clinical studies.Translate raw clinical data into compliant SDTM domains according to CDISC standards and sponsor requirements.Develop and maintain SDTM specifications and mapping documentation.Perform hands-on SAS programming to create, validate, and quality control SDTM datasets.Ensure SDTM deliverables are submission-ready and compliant with regulatory standards.Collaborate with Biostatistics, Data Management, and Clinical teams to resolve data and mapping issues.Review CRFs, CRF annotations, and protocols to ensure accurate SDTM mapping.Support regulatory submissions and respond to data-related queries as needed.Top Requirements10–15+ years of statistical programming experience in clinical research, preferably with small to mid-sized sponsor companiesExtensive expertise in CDISC SDTM standards with strong hands-on SDTM mapping and implementation experience for oncology trialsOncology experience required, with solid tumor experience strongly preferred (RECIST criteria)Advanced SAS programming skills with a focus on SDTM dataset creation and validation.Experience preparing SDTM datasets for regulatory submissions (e.g., FDA/EMA).Ability to work independently and serve as an SDTM subject matter expert within the programming team.Excellent communication skills and ability to collaborate effectively in a cross-functional environment.